ABOUT US

Federico Goodsaid, PhD

Principal

 

Bio

 

Federico Goodsaid, Ph.D., has extensive FDA, therpaeutic and diagnostic industry experience in the development of optimized and novel regulatory strategies and policies for precision medicine products, leading to efficient regulatory pathways for product approval by regulatory agencies throughout the world.

 

He is currently Principal Consultant at Regulatory Pathfinders, LLC, a consulting firm focusing on product development, biomarkers, and regulatory strategies for therapeutic and diagnostic products in oncology, lupus, liver, and other diseases. He was previously Vice President for Assay Development and Regulatory Affairs at TOMA Biosciences, where he worked on the development and regulatory submission of Next-Generation Sequencing oncology panels for DNA in tumor biopsy samples in oncology. As Vice President for Strategic Regulatory Intelligence at Vertex Pharmaceuticals, he focused on early and effective collaborative interactions with regulatory agencies on exploratory, enrichment and surrogate biomarkers. At Vertex, he successfully set up a pre-submission seamless communication of critical biomarker data leading to a timely consensus with regulatory agencies on clinical trial design and on labeling language. Before his work at Vertex, he was Associate Director for Operations in Genomics and Biomarker Qualification Coordinator at the Office of Clinical Pharmacology/Office of Translational Sciences/ Center for Drug Evaluation and Research/ U.S. FDA, where he chaired Voluntary Exploratory Data Submission (VXDS) and developed the Pilot Biomarker Qualification Program (BQP). He coordinated development of the C-Path Institute Predictive Safety Testing Consortium and other industry/government collaborations to encourage submission of biomarker qualification requests to the FDA BQP. He has also worked on the development of genomic biomarker platforms and applications as a Senior Staff Scientist at Applied Biosystems, where he developed the first TaqMan and Sybr qPCR commercially available universal master mix and target-specific reagents, and as Lead for the Molecular Toxicology Group at the Schering-Plough Research Institute, where he designed the first nonhuman primate toxicogenomic target sequence qPCR reagents. His B.A. was in Biochemistry and Biophysics from the University of California at Berkeley and his Ph.D. from Yale University in Molecular Biophysics and Biochemistry. He was a Postdoctoral Fellow at Cornell University and at Washington University in St. Louis.

Areas of Expertise

 

  • development of optimized and novel regulatory strategies and policies for precision medicine products, leading to efficient regulatory pathways for product approval by regulatory agencies throughout the world

  • breakthrough therapies

  • rare diseases

  • surrogate endpoints

  • patient selection biomarkers

  • companion diagnostics

 

Outlook

 

Medical product development is a biomarker-driven task. Its success depends on the effective use of biomarkers and the effective communication with regulatory agencies of the scientific and clinical information supporting the use of these biomarkers. Strategic Regulatory Intelligence is a valuable tool for a successful communication with regulatory agencies of the science behind biomarkers. In addition to this effective communication, however, the path for regulatory approval of novel precision medicine products may not be currently prescribed as it is for other products. Regulatory Pathfinding may be needed for an accurate path to regulatory approval for precision medicine products.

STRATEGIC REGULATORY                      REGULATORY                REGULATORY

INTELLIGENCE                                          PATHFINDING              APPROVAL

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